Z-2657-2023Class II

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators

Name: Z-2657-2023 Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators
Creator: Medtronic Neuromodulation
Published: 2020-07-17
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2020-07-17 / Terminated / root cause: software

FDA source

Medtronic Neuromodulation began a recall of Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators on 2020-07-17. FDA classified it as Class II and gives the reason as "The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2657-2023
Classification: Class II
Status: Terminated
Initiated: 2020-07-17
Posted: 2023-09-29
Terminated: 2024-09-27
Recalling firm: Medtronic Neuromodulation
Product: Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
Root cause tag: software
FDA root cause: Software design
Action: Letters dated July 2020 and flagged as "URGENT: MEDICAL DEVICE CORRECTION RESTORE CLINICIAN PROGRAMMER APPLICATION SOFTWARE UPDATE Model A71100" were issued via USPS Priority First Class Mail on 7/17/2020. The letter provided an issue summary and informed the consignee the updated version of the A71100 application was now available for download and installation for resolving the issue. The consignee was to follow the instructions provided with the letter to update the application and if assistance was needed, contact information was provided for the Technical Services team support. Once the required update is made, the action will be tracked through the firm's mobile software deployment systems and no additional reply was needed from the consignee. The letter also explained patient risk, how to identify the issue, and conditions resulting in the issue. The letter was to be shared as appropriate with those in the consignee's organization who require the information.
Quantity in commerce: 2,408 devices
Distribution: Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
Product codes and lots: Version 1.0.4232, UDI-DI 00763000273668.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2657-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2657-2023	Class II	Terminated	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)